Fat composition for infants&#39; food



Patented Sept. 23, 1952 V UNITED STATES PATENT OFFICE I V v 2,611,706 i. i 1 V FAT COMPOSITION son INFANTS FOOD H I F inn W. Bernhart, Holt, and John B. Hassinen, v

Mason, Mich., assignors toWyethIncorporated,

Philadelphia. Pa., a corporation of Delaware No Drawing.

This invention relates to a novel food composition having a milk base, which is particularly adapted when ingested to'promote the growth of acid-forming bacteria in the. human colon. Our composition contains a carbohydrate such as lactose, dextrin, or inulin that is incompletely absorbed in the stomach or small intestine, and its fat component consists of a blendof food fats, at least one being of vegetable-origin, that is free of C4-Cmsaturated fatty acids, *contains only a smallpercentage of 612-014 saturated fatty acids and contains alarge' fraction of unsaturated food fatty acids a substantial portion of whichis oleic acid. Our. food composition is particularly .adapted to'beused. as an infants:

food,- but-is-ralsowell adapted to general dietetic use.

Since the daysiof Metchnikoffs studies (see for example Etude sur'tla Nature Humaine,"Paris, 1903," and EssaisOptimistes;Engl. translation, London; '1917), the relationship *of intestinal flora to human well-being has been the subject of many investigations and has aroused considerable controversy. It is now widely accepted that a predominance of acid-forming bacteria such as L. bifldus in the colon and stools is desirable. More -cparticularly'it has been shown that the stools of normalbreast-fed infants'havea flora predominating in acid-formingrbacteria of the L. bifidustype '(e. g. gram positive rods .95-100% and a somewhat more acid-reaction, (e. g. in the neighborhood of pH 5.9), than .isthecase with pH values less than 6. p

Many efiorts have been made to' establish a H favorable colonic fioraby special dieting, as by. ingesting large amounts of fermented milk such' as -yoghurt, kumiss, and the'like, but such results have not,- in general, been successful; 1 Orla-Jensen and his co-workers have pointed,

50% andreaction in the neighborhood of 'pI-I' Application December'2I, 1949, 7 Serial No. 134,344 y 13 Claims. (Cl- 99118)' teria differing fromthose found in people, who. do not consume these products. V

The predominant lactic acid bacteriain'the feces of healthy persons are the so-calledenterj -ococci, two rodeshaped bacteria, Thermobaq f terz'um intestinale (formerly called Bacillus. acidophilus), and the forked anaerobic Beef-f terz'um bifidum which are found in large num--,. bers. The latter, which was originally thoughtto. be found only in thefeces of babies, isin fact present in large number'sin the feces of adults J and may sometimes constitute half of. the bacf-jterial population.

The same authors notefurther that a requisite for the establishment of a favorable acid-form ing colonic flora .is that sugar be availablein the. colon. Since the ordinary food sugars, sucrose... dextrose and fructose, in dietary amounts are completely absorbed 'in the small intestine, another sugar must be provided; the choiceseems limited by practical considerations ordinarilylto lactose and dextrin .with inulin as a furtherchoice under special circumstances. I

More recently it hasbeenfound that thefood e fats present inthe colon play a controlling part i in the development of an acid-forming micro-l flora, certain fractions .of. these fats being toxic to the-acid-forming bacteria; I Q It is one object of ourinvention .tqprovide a vmilk-base food composition the fat component of which; is non-toxic; to beneficient .aciclr-form ing-bacteriainthe humancolon. i

It is another object of our invention to provide such a composition in an economical manner without the necessity of expensive chemical processing of the fat constituents.

It is a further object of our invention to provide a food composition containing the non-toxic out (J. Gerontology, 01. 411949); 5-15 that widely different species of lactic acid'bacteria ex--- ist and are more or less specific to different animal species. .They state (page 7) Most of the'lacticacid bacteria of milk c an-.

milk or Yoghourt one rarely finds lactic acid bacl- I fat component together with an adequate amount of lactose, dextrin, or inulin to promote the growth .of beneficent acid-forming bacteria such as'L': bifidus in the human colon when ingested .j .the following description.

We have discovered that a readily digestible fat component which is non-toxic to L. bifidus can be made by blending easily available food fats, provided the fats are so chosen that the blend will "have 'a satisfactory melting point, be free of jglycerides of certain low-molecular weight fatty acids,v have a restricted content of glycerides of certain intermediate molecular weight fatty jacids and contain glycerides of oleic acid or equivalent unsaturated food fatty acids. Preferably also our fat composition should contain at least one vegetable fat, since the tocopherol content of vegetable fats affords antioxidant protection against development of rancidity.

We use. the term fat here and in the claims in its broad sense to include both .solid fats and fatty oils.

It has been shown that digested cows milk and the steam distillate of digested cows milk is toxic in vitro to L. bifidus. We have discovered :that the lower saturated fatty acids contained in food fats, when tested individually, vary withtheir molecular weight in their in vitro ;toxi'city'to L. bifldus. The C4 and C6 acids 'showlittle or no toxicity; toxicity rises with molecular'weightioca maximum in lauric acid, having a C12 skeleton, and then falls off; the acids containing .16 or more carbons (C16 being non-toxic. From a practical standpoint, aifat mixture free of Cr-Cmfatty acids and containing not "over about percent (ha-C14. 'fattyiacids, when "ingested, is non-toxic'ztoi. bzfidus. "Since this'bariillusrequires unsaturated fatty acids *for its growth, a dietaryialt adapted to promote the growth of L. "bifidus should have'tan adequate content "of unsaturated food acids such as oleie, linolei'c, ara'chidonic, etc. Practicallm'wghavefound that at least 2;:50 percent'conten't'of such acids is 'desirablegalarge fraction 'being oleic acid. The melting rpointishould' be in the range 25 45 'C. The "fat mixture must be free'of repellent taste and odor.

Expressed analytically, thefat component of ourzioodmomposition should "have'a saponification number in the "range 190 200, and a Wijs iodine'number "in the range "5 5:85.

In utilizing ourfat composition in a milkbase food'product-,*we preferably associate it with a sugar *or sugar-yielding carbohydrate which is incompletely absorbed in the stomach or'small intestine, such as lactose, dextrin,-or inulin,lactose in general fbeing preferred. The fat component ofpur "food composition in conjunction with ssuch "a carbohydrate exercises a stimulating efiect on thegrowth'of'L. bz'fi'dus in th'ecolon.

"Since -the keeping qualities of prepared foods against rancidity. Corn oil, cottonseed oil, olive oil, palm oil, peanut oil, sesame oil and soybean oil, for example, are all reported to have a substantial tocopherol content, ranging from about 3 mg. 100 g. for palm oil to 70-90 mg./ 100 g. for refined cottonseed oil; soybean oil has an intermediate content .tin the neighborhood of 20 mg./ 100 g.

An example of a satisfactory fat component of "a'iood composition embodying our invention is one contaim'ngfifl parts oleo oil, 30 parts corn oil and 19 parts soybean oil. One part of lecithin .is added *to -furnish choline and facilitate the absorption :of fats and oil-soluble vitamins.

The'fatty-acid contribution of each of the fat ingredients to our composition is shown in Table TLihased on the average of typical analyses of each of .the fats. The percentages of fattyacids shownhere and elsewhere in this application are percentages of the total fatty acids present in the fat in-question. They -are present forthe most part initheform of triglycerides. 'Of course, asin the case of all natural products, the relative amounts of the fatty acids in each :eons'tituent is subject'to :minor 'variationsaroundthe typical average, but the table gives-a fair representation of the character :of the individual constituents and of the -blended 'ifat.

As stated abovepsuch a'fat mixture isparticularly adapted iorrincorporation in-a milk-base infants rfood. :Sucha :foodgproperly formulated, closely simulates .human milk inits functioning, particularly asito 'weight'inerease, stimulation of a colonic .L. bifidusfiora and the tformation'o'f are of great importance, weincorporate asa constituent of our composition at least one fatty oil of vegeta'ble'origin, preferablya "seed oil. The natural tocopherolcontent of such oils acts as an antioxidant and thus guards the composition acid .stools of .about :pHT 5:9. Surprisingly, h'owver,rit;hasrbeen foundtbest notto duplicate exactly the fatty acid constituents of human milk fat. Theiatzof. humannnilk ;contains:aitrace of Ce, .about 2 "percent :of C10, :nearly *5 percent :of C12, and over 6 :percent of C14 saturated fatty acids, theseacidssinglybeing definitely toxicrtto L. :biflduszin vitro. Whole human .milk. .however, is motistoxic tbuti'stimulating 'to L. fbifldus. The reason for ?this *apparent :paradox is znot known; it :may :conceivably "be 'due to an unidentified protective agent:in human milk :or-to tan undetermined complex ofsother conditions. In any event our :compositionravoids th :necessity of providing a protective agentor the like'by containing fatentirelyfree of C10 and lower acids and having only'tolerated small percentages or C'iz' and C14 acids.

Table? Percent in fat Percent in fat component (calm) Fatt Acids y Oleo -'Corn Soybean Soybean Total- .Oil Oil vOil 50% 336% Oil-19% 99% Saturated:

C(- m .1111 I111 nil .Dfl ml 111] .1111 On Laurie 0.1 111i nil 0.05 nil nil 0.05 Cu Myristic. 3.0 mil 0.1 1.50 mi 0.02 1.52 Cu "Palmiticnn 29.0 8.0 v 8.0 "14. 50 2.40 1.52 18.42 Gm Stearic "20.0 3.5 410 10500 "1.05 "0.76 11.81 0:0 Arachidic--- 0.8 0.75 0.15 0.40 0.15 0.01 0.50 Cu Bohemia..." nil nil nil n l nil nil 1111- 0:4 'Lig-noceric... nil 0.2 ml ml 0.06 ml 0.06 Unsaturated: w a

O14 Myristoleicn 0.5 .1111. 0.1 0.25 ml, 0.02 0.27 Cu Palmitoleic- 2i 0 nil 0.2 1.0 ml 0.04 1. 04 C1! Oleic 42.0 246.0 .-28.0 21.0 .13.-.80 .5;33 i40.13 .0 Linoleicmu. 2:0 n o 54.10 1.0 12.5 "10.25 23.35 5 Linolenicun 0.5 nil "5.0 .0525 nil 0.9 5 11.20 00 0 :Arachidonic- 0.1 nil ml. 0.05 .nil ml 0.00

Tct'al--. 100:0 .1100; 2 10110 50.00 230.100 18; .9836

I .Iodinanumber '(Wiis), 84.

Saponiflcation number,.l95. Meltingpoint, 29' Cl.

While Table I illustrates'an embodimentof our fat 'componentma'd'e up of oleo, corn and soybean oils, other blends of food oils maybe used, as. will be well understood bythose skilled in the art; provided they conform to the requirements set forth above and in the appended claims.

Another desirable fatblend is the following, I

which contains palm oil:

Oleo oil Oleic+1in0leic acids 51%. Corn oil 0 -010 acids nil. Soybean oi1.. 012-014 acids 2.2%.. Palm oil Iodine No. 61.

p SaponificationvaluelQS.

Total 100% p Additional fat blends'meeting the requirements 1 of our invention are:

0190 stock 'Oleic-Hinoleic'acids 59%. Oleocil W OhOmacids nil. Soybean oil C12- Cu acids 1.8%. Soybean lecithin- Iodine No. 78. Cottonseed oiL... Saponification value 194.

Total 100% Mutton tallcw 25% Oleic+lino1eic acids 60%. L d 4O 04-010 acids nil.

- 0 2-0 acids 0.13%.

Iodine No.76.

Sa'ponification value 194.

corporating our fat .component described in Table I has the following formulation One example of a' milkrbasefoodproduct in- 6 In makingethis' product, .theskim milk is preheated. to 77 6., drawninto a blending tank and mixed with aprevious'lyiprepared mixture of the sodium caseinate; lactose and imelted fat. During and after blending the mixture is held:

at pasteurizing temperature fornseveral' hours,

clarified, homogenized andcooledp .The minerals at suitable :points in";

and vitamins are. added these operations. I

The resulting liquid andcanned for distributionas a liquid-z milk food concentrate, requiring dilution with water is concentrated." .under vacuum to approximately half itsoriginalvolume before use. Alternatively it may be spray-dried;

and distributed as a powdered solid concentrate.

Wehave found that our fat component permits such concentration without separation; of

a fat layer. When canned at. a. concentration requiring dilution with an equatvolume of water. i: for use,-it has along shelf life without -1sep- Q aration of a fat layer; such creaming as may occur on prolonged storage isreadily 'dispersible by shaking with or without gentle warming. fj

Such a food composition may also be dried i to a powder which is readily "soluble and dispersible in water, as by spray-drying. dryingin a vacuum drum drieror the like." .Inthis case 2 the sodium cas'einate is preferably omitted from; I

the formulation.

The milk food described aboveiTable IDf has been tested clinically with infants and found to yieldexcellentresults in providing satisfactory weight'gaimincreasing the L. bifidus' flora and correcting deficient acidity of the stools.

Asian example, three infants ranging in age from one'to twolmonths'and in weight from 6 to 7 /2 ,lb.', who had previously beenfed a 0011-.

ventional evaporated-milk formula, "were put on a diet consisting of our above described milk.

food and observed for 52 days. The percentage of gram positive rods in the flora of the stools hadincreased to 80-90percent andthepH had;-

dropped to an average of 5.9. infants had; increased in weight 3 lb. to 9 -10 lb. This isa gain of approximately 1oz. per day. The in.- 1 fants tolerated the food well and were in excelooaru; t ndltion at the end of the observation p r j BamckMmemls and Vitamins Additional details are sown in Table III.

Table III Infant Lw Mk L Mb '1 Sex female female ale Weight: at birth 4 lb. 14% oz.. 71b. 4% oz. -6 lb. 5 oz.

2 weeks before'startmg new di A. 6 lb. 33 oz. 3 4days befores mg new diet. 7 lb. 4 oz. 4

. At start of new diet: age. days 37 Percent Gram positive rods '9 in stool flora 63 55 53 pH of stools I 7.2 7.4 6.6 After 24 days on new diet: Weight. 8 lb. 11 oz. -9 lb. 6 oz 8 lb. 4 oz.

After 27 days on new diet: 7 Percent Gram positive rods instoo1flora. g 89 Q 87 .1 -"-jf- I pH ofstools 5.7 1 5.1 6.6

. After 52 days on new diet (end observation period):

Weight A 10 lb. 8 oz. 10 lb..0 oz -9.lb. 8 oz. Percent Gram pos1t1ve rods in stool flora 91 v .80 '90 pH of stools 5.7 6.4. .--.5.0

Comparative "feedings were also .carriedou-t with a well known proprietary infants food allresp'ects identical with that disclosed in-Table II except that its fat componenthad a substantialperc'entage of C6-C1; fatty acids. diet the stools 'had substantially the same microflora' and' pH as with .the evaporated milk formula. This indicates that the favorable results in these respects obtained with our milk food were due to. the selected fatty-acid content of the fat component-in our milk food.

The compositionof such a food may be varied within-certain limits without losing the advantages" of our invention. Practical approximate limits on a dry basisare:

. Percent skime-milkisolids-new-..ma num..- 25-45 Lactoseewflflwwnden-...... 35-60 Casein. sal

Fat component of this. invention -40 We claim: 11A food composition comprising a carbohydrate component selected from the group consist-- ing of lactose, dextrin, inulin and mixtures thereof, anda fat component consisting of a blend of a plurality of food fats, at least one of which is of vegetable origin, said blend containing only those saturated fatty acids having more than 10 carbon atoms in the molecule, containing not over 5% of Ciz-Cnsaturatedfatty acids, containing at least 50% of unsaturated fatty acids of which'a substantial fraction is oleic acid, said percentages being by weight based on the total weight of the fatty acidspresent in said fat component, said blend of a plurality of food fats having a saponification number within thenrange 190-200, a Wijs iodine number within the range 55-85, and a melting point within the range 2..In amilk-base food composition, in com- With this I binationwith mill; solidsdcrived from skim milk and an added carbohydrate selected. from the group consisting of lactose, dextrin, inulin and mixtures thereof: 'a fat component consisting of a blend of'foo'd fats, at least one'of aplurality of which'is of vegetable origin,.the blend containing only those saturated fatty acids having more thanlO carbon atoms'irnthe molecule containing only a small percentage of C -Cm saturated fatty acids; containing at least percent unsaturated fatty acids of which a substantial fraction 'is oleic acid, the fatty acid percentages' beingbased on the total fatty acids in the fat, andhavinga 190-200, a Wijs iodine number within the range -85 and a melting point within the range 25-45 C. whereby said composition on ingestion promotes the growth of acid forming bacteria in' 5. A food composition as defined in claim 2 in which the fat component consists of oleo oil, corn' oil, soybean oil and palm oil. 7

- saponification number falling within the range 6. A food composition as defined in claim 2 in. which the fat component consists of oleo stock,

oleo oil, soybean oil, cottonseed oil and a small amount of soybean lecithin.

7. A'fo'od composition as defined in claim 2" in which -the fat component consists of mutton tallow, lard, cottonseed oil, soybean oil and corn oil.

8. A food; composition comprising skim-milk solids,.lactose, minerals, vitamins, lecithin, and

a fat component consisting, of a blend of arplurality of foodfa'ts, at least one of which is of vegetable'origin, the blend. containing only thosesaturated fatty acids having more than 10 carbon atoms in the molecule, containing-not over 5 percent 012-014 saturated fatty acids, containing at least 50 percent unsaturated fatty acids of which a substantial fraction is oleic acid, the fatty acid percentages-being based on the total fatty acids in the fat, and having a melting point in the range 25-45 0., whereby said composition on ingestion promotes the growth of acid-forming bacteria in the human colon.

9. A food composition comprising a homogenized mixture of skim-milk solids, lactose and a fat component -in the followingpercentage ranges:

v Percent Skim-milk solids 25-45 Lactose N 35-60 Fat component -1 -e 15-40 range 25-45 0., whereby said composition on "ingestion promotes the growth of acid-forming bacteria inthe human colon.

10. A "food composition as defined inv claim 9,"

of lactose, dextrin, inulin andmixtures thereof,

a fat component, vitamins and minerals, said fat component being present in an amount ranging from. 1.5% to 40% of the dry weight of said food composition, said fat component consisting of a blend of aplurality of food fats comprising at least one vegetable oil of substantial tocopherol content selected from the group consisting of corn oil, cottonseed oil, olive oil, palm oil, peanut oil. sesame oil and soybean oil, said fat component containing only those saturated fatty acids having more than 10 carbon atoms in the molecule, containing not over 5% of 012-014 saturated fatty acids, and containing at least 50% of unsaturated fatty acids of which a substantial fraction is oleic acid, said percentages being by weight based on the total fatty acid content of said fat component, said blend of food fats being further characterized by a saponification number within the range -200, a Wijs iodine number within the range 55-85, and a melting point within the FINN W. BERNHART. JOHN B. HASSINEN.

(References on following Page) 9 REFERENCES CITED The following references are of record in the file of this patent:

UNITED STATES PATENTS Number Name Date 782,820 Bloom Feb. 21, 1905 782,821

Bloom Feb. 2 1, 1905 10 OTHER REFERENCES Dietotherapy-Clinical Application of Modern Nutrition, by Woh1-W. B. Saunders Company, Philadelphia and London, 1945pag.es 474-486, 489 and 490. I 

1. A FOOD COMPOSITION COMPRISING A CARBOHYDRATE COMPONENT SELECTED FROM THE GROUP CONSISTING OF LACTOSE, DEXTRIN, INULIN AND MIXTURES THEREOF, AND A FAT COMPONENT CONSISTING OF A BLEND OF A PLURALITY OF FOOD FATS, AT LEAST ONE OF WHICH IS OF VEGETABLE ORIGIN, SAID BLEND CONTAINING ONLY THOSE SATURATED FATTY ACIDS HAVING MORE THAN 10 CARBON ATOMS IN THE MOLECULE, CONTAINING NOT OVER 5% OF C12-C14 SATURATED FATTY ACIDS, CONTAINING AT LEAST 50% OF UNSATURATED FATTY ACIDS OF WHICH A SUBSTANTIAL FRACTION IS OLEIC ACID, SAID PERCENTAGES BEING BY WEIGHT BASED ON THE TOTAL WEIGHT OF FATTY ACIDS PRESENTS IN S AID FAT COMPONENT, SAID BLEND OF A PLURALITY OF FOOD FATS HAVING A SAPONIFICATION NUMBER WITHIN THE RANGE 190-200, A WIJS IODINE NUMBER WITHIN THE RANGE 55-85, AND A MELTING POINT WITHIN THE RANGE 25-45* C. 